Real World Data and Evidence: Support for Drug Approval: Applications to Kidney Diseases

Clin J Am Soc Nephrol. 2019 Oct 7;14(10):1531-1532. doi: 10.2215/CJN.02790319. Epub 2019 Sep 6.

Authors

Aliza M Thompson¹, Mary Ross Southworth

Affiliation

¹ Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.

No abstract available

Keywords: Drug Approval; kidney diseases; real-world evidence.

MeSH terms

Clinical Trials as Topic / methods
Clinical Trials as Topic / statistics & numerical data
Data Interpretation, Statistical
Drug Approval / statistics & numerical data*
Humans
Kidney Diseases / drug therapy*
United States
United States Food and Drug Administration